The Comparison of Low Thoracic Paravertebral Block Versus Peritubal Infiltration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Percutaneous nephrolithotomy (PCNL) is a safe and effective procedure that is considered the standard treatment for large and complex renal stones. Although it has lower complication and morbidity rates than open surgery, the pain and discomfort related to a nephrostomy tube can cause distress for patients.

Managing this pain with opioids can lead to sedation, nausea, vomiting, and constipation, which defeat the purpose of this minimally invasive procedure.

Skin infiltration with bupivacaine around the nephrostomy tube is not effective. Infiltration of renal capsule has shown to facilitate painless insertion of nephrostomy tube, suggesting the role of renal capsule in pain management.

Peritubal infiltration of bupivacaine from renal capsule to the skin along the nephrostomy tract may alleviate postoperative pain. A unilateral Low thoracic paravertebral (PVB) block offers the option of providing extendable perioperative pain relief without the above side effects or the physiologic derangement associated with local anesthetics in the central neuraxial space.

The aim of this study is to determine whether ultrasound guided low thoracic paravertebral block effective post-operative analgesia as compared to peritubal infiltration analgesia in patients undergoing percutaneous nephrolithotomy.

Main outcome measures: The primary endpoint is postoperative opioid consumption. Secondary endpoints are visual analogue pain scores, opioid related side effects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ultrasound-Guided Intercostal Nerve Block for Postoperative Pain Relief in Percutaneous Nephrolitotomy

NCT01549405

Nerve Block, Intercostal Nerve

COMPLETED NA

Analgesic Efficacy of Ultrasound Guided Quadratus Lumborum Block During ESWL

NCT03080363

Pain, Acute

COMPLETED PHASE4

Ultrasound Guided Anterior Quadratus Lumborum Block

NCT03425162

Postoperative Pain Ultrasound

COMPLETED NA

Comparison of Paravertebral Block and Subcostal Transversus Abdominis Plane Block in Laparoscopic Nephrectomy

NCT05723341

Analgesia Anesthesia Pain, Postoperative

COMPLETED NA

Paravertebral Block Versus Erector Spinae Plain Block In Percutaneous Nephrolithotomy

NCT04998435

Renal Stone Nephrolithiasis Analgesia +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Percutaneous Nephrolithotomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low thoracic paravertebral block

T8-T9 Ultrasound guided paravertebral block with 20 ml %0,25 bupivacaine

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

20 ml %0,25 bupivacaine

Ultrasound

Intervention Type DEVICE

Peritubal infiltration

Peritubal infiltration with 20 ml %0,25 bupivacaine

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

20 ml %0,25 bupivacaine

Control Group

No drug

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bupivacaine

20 ml %0,25 bupivacaine

Intervention Type DRUG

Ultrasound

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* American Society of Anesthesiologist's physiologic state I-III patients undergoing percutaneous nephrolithotomy

Exclusion Criteria

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No